EYE TREATMENT DEVICE INCLUDING INDEXING MEANS
The device addresses the cost and positioning issues of existing glaucoma treatments by incorporating a transparent indexing module and gripping mechanism, ensuring stable and efficient treatment of multiple eye sectors with reduced manufacturing costs.
Patent Information
- Authority / Receiving Office
- FR · FR
- Patent Type
- Patents
- Current Assignee / Owner
- EYE TECH CARE
- Filing Date
- 2024-04-11
- Publication Date
- 2026-04-17
AI Technical Summary
Existing glaucoma treatment devices are costly and lack real-time monitoring capabilities to ensure proper positioning during treatment, necessitating improved manufacturing and positioning stability.
A treatment device with a ring and ultrasound generation unit that allows rotation in multiple positions, featuring a transparent indexing module and recessed areas for visual verification, along with a gripping mechanism to maintain stable positioning during treatment.
Ensures stable device positioning during treatment, reducing manufacturing costs while allowing effective treatment of multiple eye sectors without manual repositioning, enhancing treatment efficacy.
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Abstract
Description
Title of the invention: EYE TREATMENT DEVICE INCLUDING INDEXING MEANS FIELD OF INVENTION
[0001] The present invention relates to the general technical field of devices — in particular probes — for the non-invasive treatment of an ocular pathology by generation of focused or unfocused ultrasound, of high or low intensity.
[0002] More particularly, the invention relates to a processing device including: • a ring intended to be handled by a practitioner, and • an ultrasound wave generation unit for the treatment of an ocular pathology, for example the treatment of glaucoma.
[0003] BACKGROUND OF THE INVENTION
[0004] 1. General Information
[0005] Glaucoma is an optic neuropathy, that is to say a degeneration of the optic nerve, which very often leads to an increase in Intraocular Pressure (IOP).
[0006] When the aqueous humor is no longer drained sufficiently quickly, it accumulates, leading to an increase in intraocular pressure (IOP). The increased IOP compresses the axons in the optic nerve and can also impair the optic nerve's blood supply. Prolonged elevated IOP can lead to total vision loss.
[0007] The only currently available therapeutic approach to treat glaucoma is to reduce intraocular pressure: • either by improving the drainage of aqueous humor through the trabecular meshwork and Schlem's canal of the eye, • either by reducing the production of aqueous humor by the ciliary body of the eye.
[0008] 2. Prior art
[0009] A device for reducing aqueous humor production based on the principle of cyclocoagulation by High Intensity Focused Ultrasound is known from document WO 2021 / 122765, which consists of destroying part of the ciliary bodies in order to reduce aqueous humor production.
[0010] This device comprises: • an ultrasound generation unit comprising a cylindrical cradle, and one (or more) transducer(s) fixed to the cradle, • a handpiece comprising a gripping body and a rotating head intended to be coupled to the ultrasound generation unit to allow the transducer to be moved into a plurality of positions in order to treat different sectors of the patient's eye, and • a ring adapted to receive the ultrasound generation unit.
[0011] Thus, the device according to WO 2021 / 122765 makes it possible to treat several areas distributed over the entire circumference of an eye without requiring the practitioner to carry out a repositioning operation of the ring between each emission of ultrasound.
[0012] Even if the device according to WO 2021 / 122765 is effective, there is a need for a treatment device with a reduced manufacturing cost. Furthermore, there is a need for a treatment device whose positioning on the patient's eye can be monitored in real time by the practitioner during treatment. This allows the practitioner to ensure that the device does not move and remains correctly positioned throughout the treatment to guarantee its effectiveness.
[0013] One object of the present invention is to provide a solution to the problem described above.
[0014] BRIEF DESCRIPTION OF THE INVENTION
[0015] To this end, the invention relates to a device for treating an ocular pathology, the device extending along a longitudinal axis and comprising: • a ring configured to be positioned on an eye to be treated, the ring comprising: • a truncated cone designed to come into contact with the eye to be treated, • a gripping ring including a cylindrical side face and extending over the truncated cone, • an ultrasound generation unit configured to be mounted on the ring, the ultrasound generation unit being adapted to move in rotation about the longitudinal axis relative to the ring in a plurality of successive treatment positions, the ultrasound generation unit comprising: • a cradle, including at least two transducers, • an indexing module defining the successive processing positions, the indexing module including a cylindrical shaft whose external face is intended to come into contact with the internal face of the cylindrical side facade.
[0016] Advantageously, and as will be described in more detail later: • the cradle has two hollowed-out areas (referenced ZE1 and ZE2 on [Fig.7]), and • The indexing module is made of a transparent material.
[0017] The transparency of the indexing module, combined with the recessed areas of the cradle, allows the practitioner to visualize the patient's eye through the device. The practitioner can thus verify the position of the device on the patient's eye throughout the treatment. This allows the practitioner to ensure, by simple visual inspection, that the device does not move during the treatment.
[0018] In the context of the present invention, "extending over" means a first element disposed directly above a second element, or disposed indirectly above the second element, a third element extending between the first and second elements.
[0019] Preferred, but not limiting, aspects of the treatment device according to the invention are as follows: • in certain embodiment variants: • the inner face of the cylindrical side facade may have longitudinal grooves extending parallel to the longitudinal axis, • The indexing module may include an indexing tab housed in a notch in the cylindrical barrel, said indexing tab including an elastic leg, and a longitudinal bead configured to cooperate with the longitudinal grooves, the longitudinal bead extending in projection on the external face of the elastic leg, parallel to the longitudinal axis, the indexing tab being pivotally mounted about a pivot axis perpendicular to the longitudinal axis, said indexing tab being movable between: • a rest position in which the indexing tab extends in line with the cylindrical shaft, the longitudinal bead being housed in a longitudinal groove in the rest position so that rotation of the ultrasonic generation unit relative to the ring is prevented, and • a disengagement position in which the indexing tab is inclined towards the inside of the cylindrical barrel, the longitudinal bead being clear of the longitudinal groove in the disengagement position so that the rotation of the ultrasound generation unit relative to the ring is permitted; • the plurality of successive processing positions may include an initial processing position, a final processing position, and at least an intermediate treatment position between the initial and final treatment positions, the device including a stop mechanism to prevent rotation of the ultrasound generating unit relative to the ring when the ultrasound generating unit is in the final position; The stopping mechanism may include: • at least one guide lug extending over the outer face of the cylindrical shaft and configured to cooperate with an annular groove formed in the inner face of the ring, said and at least one guide lug moving inside the annular groove during the rotation of the ultrasound generation unit relative to the ring, and • at least one nipple housed in the annular throat, said and at least one nipple being in contact with said and at least one spur when the ultrasound generation unit is in the final position; advantageously: • the cylindrical side face of the gripping ring may have a rim opposite the truncated cone, said rim including positioning marks, each mark being associated with a longitudinal groove to identify one of the plurality of processing positions, and • the cylindrical shaft may include a collar intended to come opposite the rim, said collar including a hole, the hole extending above a positioning mark when the longitudinal bead is housed in the longitudinal groove associated with said positioning mark; the cylindrical shaft of the indexing module may include a crenellated collar intended to come into contact with an edge of the gripping ring, said collar forming a gripping means enabling the practitioner to rotate the ultrasound generation unit relative to the ring; the gripping ring may include a pair of pins extending radially outwards from the cylindrical side face, and a pair of through openings allowing the flow of any excess coupling fluid contained in the ring, each through opening being positioned under a respective pin of the pair of pins; the ring can be made of a transparent material; The elastic band, the longitudinal ridge, and the longitudinal grooves can be configured so that the application, by the practitioner, of a Tangential force to the ring and perpendicular to the axis induces the movement of the tongue from the rest position to the disengaged position if said force is greater than a threshold value. Brief description of the drawings
[0020] Other advantages and features of the processing device according to the invention will become clearer from the following description of several embodiments, given by way of non-limiting examples, based on the accompanying drawings in which:
[0021] [Fig-1] is a schematic exploded perspective representation of a device for treating an ocular pathology,
[0022] [Fig.2] is a schematic perspective representation of a ring of the processing device,
[0023] [Fig.3] is a schematic exploded front view representation of the ring illustrated in [Fig.2],
[0024] [Fig.4] is a schematic perspective representation of the ring illustrated in [Fig.2] and of an ultrasound generation unit,
[0025] [Fig.5] is a schematic perspective representation of a gripping ring of the ring illustrated in [Fig.2],
[0026] [Fig.6] is a schematic exploded perspective representation of the generation unit illustrated in [Fig.4],
[0027] [Fig.7] is a schematic representation from below of a cradle of the ultrasound generation unit illustrated in Figures 4 and 6?
[0028] [Fig.8] is a schematic perspective representation seen from below the cradle illustrated in [Fig.7],
[0029] [Fig.9] is a first schematic perspective representation of an indexing module for the ultrasound generation unit illustrated in Figures 4 and 6,
[0030] [Fig. 10] is a second schematic perspective representation of the indexing module illustrated in [Fig. 9],
[0031] [Fig. 11] is a schematic perspective representation of the gripping ring and indexing module when the gripping ring and indexing module cooperate. DETAILED DESCRIPTION OF THE INVENTION
[0032] We will now describe various examples of the processing device according to the invention with reference to the figures. In these different figures, the equivalent elements are designated by the same numerical reference.
[0033] 1. General Information
[0034] With reference to [Fig. 1], the treatment device comprises: • a ring 1 intended to be positioned on the eye of a patient to be treated, • a 3-unit ultrasound generation system to treat different areas of the patient's eye, and • an electrical connection cable 2 to supply electrical power to the ultrasound generation unit 3.
[0035] The ring 1 and the ultrasound generation unit 3 are intended to be assembled together and extended along an axis A-A' to form the treatment device.
[0036] The ring 1 and the ultrasound generation unit 3 are consumables of the treatment device, while the cable 2 is reusable for the treatment of a plurality of patients.
[0037] As will be described in more detail later, the ultrasound generation unit 3 includes a pair of radially opposed transducers. This pair of transducers allows for the simultaneous treatment of two sectors of the patient's eye.
[0038] To treat more than two sectors, the ultrasound generation unit 3 can be moved in rotation relative to the ring 1 in a plurality of successive treatment positions.
[0039] 2. Processing device
[0040] 2.1. Ring
[0041] The ring 1 allows adequate and constant positioning of the ultrasound generation unit 3, both for centering and for distance relative to the sclera of the ultrasound generation unit 3.
[0042] The ring 1 is open at its ends. It includes a lower edge intended to come into contact with the eye of a patient to be treated, and an upper edge intended to come into contact with the ultrasound generation unit 3. The ring 1 is configured to be filled with a coupling fluid that allows the transmission of the acoustic waves produced by the ultrasound generation unit 3. Advantageously, the ring can be made of a transparent material. This facilitates proper positioning of the ring on the patient's eye and allows ambient light to pass through to illuminate the treatment area.
[0043] With reference to Figures 2 and 3, ring 1 comprises: • a truncated cone 11 with axis A-A' having a small base 111 and a large base 112 opposite the small base 111, • an annular skirt 12 coaxial with the truncated cone 11, said annular skirt 12 extending in a direction opposite to the truncated cone 11 from the large base 112 of the truncated cone 11, and • a gripping ring 13 coaxial with the annular skirt 12, said gripping ring 13 extending over the annular skirt 12 opposite the truncated cone 11.
[0044] In the embodiment illustrated in [Fig.3], the truncated cone 11, the annular skirt 12, and the gripping ring 13 are made in three separate components assembled by bonding to obtain the ring 1. This makes it easier to manufacture each of the components by molding, and limits the manufacturing cost of the ring 1.
[0045] Alternatively, the truncated cone 11, the annular skirt 12 and the gripping ring 13 can be monobloc, i.e. made in one piece, which limits the risks of leakage but the production cost is increased.
[0046] 2.1.1. Truncated cone
[0047] The truncated cone 11 is open at both ends. It comprises a truncated conical lateral face 113 whose end margins respectively define the small base 111 and the large base 112 of the truncated cone 11.
[0048] The small base 111 forms the lower edge of the ring 1. This small base 111 is intended to come into contact with the eye of a patient. The small base 111 may include an external annular flange adapted to be applied to the external surface of the eye, this flange having a concave profile with a radius of curvature substantially equal to the radius of curvature of the eye.
[0049] The large base 112 of the truncated cone 11 is integral with the annular skirt 12.
[0050] The truncated conical side panel 113 includes a through channel 114 intended to be connected to a flexible drain tube (not shown) which ensures that the cone 1 is held on the eye by vacuum during treatment and allows the coupling fluid contained in the ring 1 to be evacuated at the end of the treatment of the patient's eye.
[0051] 2.1.2. Ring skirt
[0052] The annular skirt 12 and the cone truncate 11 define, together with the patient's eye, an internal space intended to contain the coupling fluid.
[0053] The annular skirt 12 includes a lateral partition 123 extending outwards from the large base 112 of the truncated cone 11.
[0054] More specifically, the skirt 12 comprises first and second open terminations 121, 122: • the first termination 121 being integral with the large base 112 of the truncated cone 11, and • the second termination 122 being opposite the small base 111 of the truncated cone 11, when the truncated cone 11 and the skirt 12 are assembled.
[0055] Advantageously, the skirt 12 has a complementary shape to the ultrasonic generation unit 3. More specifically, the inner profile of the side partition 123 is the conjugate of the outer profile of the ultrasonic generation unit 3.
[0056] 2.1.3. Gripping ring
[0057] The gripping ring 13 allows the practitioner to hold the ring 11 between his thumb and forefinger.
[0058] The gripping ring 13 comprises a cylindrical side face 133 open at both ends and extending opposite the truncated cone 11 along the axis A-A'.
[0059] More specifically, the cylindrical side face 133 has first and second opposing edges 131, 132: • the first rim 131 extending over the second termination 122 of the lateral partition 123 (of the annular skirt 12), and • the second rim 132 extending opposite the second termination 122, when the annular skirt 12 and the gripping ring 13 are assembled.
[0060] The gripping ring 13 comprises a pair of pins 134 extending radially outwards from the cylindrical lateral face 133. These radially opposed pins 134 provide the practitioner with an indication of where to position their fingers to hold the ring 1. To improve grip on the ring 1, each pin 134 may have a concave surface, possibly grooved. This reduces the risk of the practitioner's surgical glove (which may be wet in some cases) accidentally slipping onto the pair of pins 134. Advantageously, the pins 134 are hollowed out in a direction parallel to the axis A-A'. This helps to limit the weight of the ring 1.
[0061] Advantageously, each pin 134 includes a through-opening 134a in its lower part. More specifically, the through-opening 134a of each pin 134 is positioned below the finger placement area of the practitioner. These through-openings 134a allow any excess coupling fluid to drain when the ring is filled with said fluid. The fact that the openings 134a are located below the finger placement areas of the practitioner prevents these placement areas from becoming contaminated with coupling fluid, which could increase the risk of the practitioner's surgical glove accidentally slipping onto the pair of pins 134.
[0062] The inner face of the cylindrical lateral front panel 133 includes longitudinal grooves 135 intended to receive a bead of an indexing module 32 of the ultrasound generation unit 3, as will be described in more detail later. Each groove 135 corresponds to a treatment position of a respective sector of the patient's eye.
[0063] The inner face of the cylindrical side face 133 also includes a recess in its lower part opposite the second rim 132. This recess makes it possible to define, with the second termination 122 of the annular skirt 12, an annular groove for guiding the ultrasound generation unit 3 during the rotational movement of the ultrasound generation unit 3 relative to ring 1.
[0064] The second rim 132 forms the upper edge of the ring 1. This second rim 132 is intended to come into contact with the ultrasound generation unit 3.
[0065] As illustrated in [Fig. 5], the outer face of the second rim 132 may have positioning marks 136, such as numbers. This allows the practitioner to know in which treatment position the ultrasound generation unit 3 is positioned.
[0066] 2.2. Ultrasound generation unit
[0067] The ultrasound generation unit 3 allows for the generation of ultrasonic energy.
[0068] As illustrated in [Fig.6], the ultrasound generation unit 3 comprises a support cradle 31 and an indexing module 32 mounted on the support cradle 31.
[0069] Advantageously, the support cradle 31 and the indexing module 32 are manufactured independently, then assembled (by gluing and / or clipping) to form the ultrasonic generation unit 3. This allows the cradles 31 to be manufactured in series, which reduces the manufacturing cost of the ultrasonic generation unit 3.
[0070] 2.2.1. Cradle
[0071] With reference to Figures 7 and 8, the cradle 31 comprises: • an external cylindrical ring 311 with axis A-A' open at both ends so that said cylindrical ring has upper and lower circular edges 3111,3112, • a pair of internal side walls 312 extending inside the cylindrical ring 311, each side wall 312 including a top edge 3121 extending in a plane containing the top edge 3112 of the cylindrical ring 311, and a bottom edge 3122 opposite the top edge 3121, and • a lower wall 313 extending between the lower edge 3111 of the cylindrical crown 311 and the lower edges 3122 of the lateral walls 312, • a pair of T transducers mounted on the lower wall 313, • two hollowed-out areas ZE1, ZE2 between walls 312 and 3111 allowing visualization of the eye during treatment.
[0072] The transducers T generate processing acoustic waves in a direction opposite to the cradle 31. Each transducer T includes a radiating element for generating the acoustic waves. The profile of the radiating element can be adapted to allow the orientation and focusing of the ultrasound to a given point. Alternatively, each transducer T may include one or more reflectors for to reflect, direct and focus, at a given point, the acoustic waves produced by the radiating element.
[0073] As illustrated in [Fig. 7], the side walls 312 and the lower wall 313 of the cradle 31 are curved. This limits the adhesion of air bubbles to said walls, and therefore the presence of air bubbles between the patient's eye and the transducers of the ultrasound generation unit.
[0074] The side walls 312 extend along chord planes of the cylindrical ring 311. This increases the rigidity of the cradle. It is thus possible to reduce the thickness of the outer cylindrical ring 311 to limit the mass of the ultrasound generation unit 3.
[0075] The side walls 312 and lower wall 313 define a receiving cavity for an electronic transducer control board. This electronic board may include memory in which transducer power supply parameters are stored. The housing is adapted to be fixed to the downstream base 311. It also contains the connection terminal(s) 323.
[0076] The side walls 312 also include a flared area for the passage of one (or more) connection terminal(s) mounted on the handpiece 2, said connection terminal(s) being intended to come into contact with the transducers to electrically connect the handpiece 2 and the ultrasound generation unit 3. Each connection terminal may include a spring-loaded electrical connector. This allows for the different mechanical tolerances related to the assembly of the handpiece 2 on the cradle 31.
[0077] 2.2.2. Index module
[0078] The indexing module 32 allows different processing positions to be defined for the transducers mounted on the cradle 31.
[0079] The indexing module 32 is made of a transparent material allowing the surgeon to view the eye through the hollowed areas ZE1, ZE2 of the support cradle 31.
[0080] Thus, the fact: • that the cradle includes hollowed-out areas, and • that the indexing module is transparent This allows the practitioner to monitor, in real time, the positioning of the treatment device on the patient's eye. This monitoring can be performed by the practitioner throughout the entire treatment. The practitioner can thus ensure that the device remains stable during the treatment, guaranteeing its effectiveness.
[0081] With reference to [Fig.9] and [Fig.10], the indexing module 32 comprises: • a cylindrical drum 321, • one (or more) guide lug(s) 322a, 322b extending over the external face of the cylindrical barrel 321, • one (or more) indexing tab(s) 323 provided on the cylindrical barrel 321.
[0082] The cylindrical shaft 321 can be composed of several superimposed cylinders of different diameters and heights. The lower end 3211 of the cylindrical shaft 321 is intended to come into contact with the cradle 31. As illustrated in [Fig.
[10] The upper end of the cylindrical shaft 321 (opposite the lower end 3211) has a collar 3212 intended to come into contact with the second rim 132 of the ring 1. The collar 3212 constitutes a gripping element enabling the practitioner to rotate the ultrasound generation unit 3 relative to the ring 1 (when said ultrasound generation unit 3 and the ring 1 are assembled), by applying a tangential support force to the collar 3212. More specifically, the shape and dimensions of the collar 3212 are adapted to allow the practitioner to grasp said collar 3212 between their thumb and forefinger.Once the collar 3212 is grasped between the practitioner's fingers, the practitioner can rotate the ultrasound generation unit 3 relative to the ring 1 (by applying the tangential support force) by pivoting their fingers around the axis A-A'.
[0083] As illustrated in [Fig.10], the collar 3212 may have a crenellated external surface to limit the risk of the practitioner's fingers slipping on the collar 3212 when the practitioner applies a tangential support force on the collar 3212 in order to induce a pivoting (along the axis A-A') of the ultrasound generation unit 3 relative to the ring 1.
[0084] Advantageously, the collar 3212 includes a hole 3213. This hole 3213 is arranged in the collar 3212 so as to extend over a positioning mark 136 when the ultrasound generation unit 3 is in a given treatment position. This provides the practitioner with an indication of the treatment position in which the ultrasound generation unit 3 is positioned.
[0085] The cylindrical barrel 321 also includes a notch extending over a non-zero height along the axis A-A', and in which the indexing tab 323 is housed.
[0086] 2.2.2.1. Guide lug
[0087] The guide lug(s) 322a, 322b allows(s): • to facilitate the assembly of the ultrasound generation unit 3 onto ring 1, and • to guide the rotational movement of the ultrasound generation unit 3 relative to the ring 1.
[0088] Each guide lug 322a, 322b extends radially outwards from the outer face of the cylindrical barrel 321.
[0089] 2.2.2.1.1. Insertion
[0090] To mount the ultrasonic generation unit 3 onto the ring 1, each guide lug 322a, 322b is designed to cooperate with a respective longitudinal groove 138a, 138b formed on the inner face of the gripping ring 13. In particular, each lug 322a, 322b is designed to slide within its associated longitudinal groove 138a, 138b. With reference to [Fig. 4], each straight longitudinal groove 138a, 138b extends longitudinally in a direction parallel to the axis A-A' from the second flange 132 of the gripping ring 13.
[0091] Each guide lug 322a, 322b forms, with its associated longitudinal groove 138, a guide facilitating the assembly and pivoting of the ultrasonic generation unit 3 relative to the ring 1. This ensures precise and repeatable positioning of the ultrasonic generation unit 3 relative to the ring 1.
[0092] In the embodiment illustrated in Figures 6, 9 and 10, the indexing module 32 comprises two guide lugs 322a, 322b, each designed to cooperate with a respective longitudinal groove 138a, 138b. Each guide lug 322a, 322b has a different profile. In particular: • a first guide lug 322a has a triangular shape; a first triangular groove 138a (complementary to the shape of the first lug) is intended to cooperate with said first guide lug 322a, • while a second guide lug 322b has a rectangular shape; a second rectangular groove 138b (complementary to the shape of the second lug) is intended to cooperate with said second guide lug 322b.
[0093] The use of guide lugs 322a, 322b (intended to cooperate with longitudinal grooves 138a, 138b of complementary shapes) having different profiles allows the practitioner to have an indication of the orientation of the ultrasound generation unit 3 relative to the ring 1, the ultrasound generation unit 3 being able to penetrate the ring 1 only in a single orientation.
[0094] 2.2.2.7.2. Rotation
[0095] Each guide lug 322a, 322b is also intended to cooperate with the annular groove (defined between the second termination 122 of the annular skirt 12 and the notch of the cylindrical side face 133 of the gripping ring 13) provided in the inner face of the ring 1, once the ultrasonic generation unit 3 is mounted on the ring 1.
[0096] The annular groove may have a rectangular profile. As illustrated in [Fig. 1 1], each longitudinal groove 138a is connected to the annular groove by one of its ends so that each longitudinal groove 138a opens into the annular groove.
[0097] 2.2.2.2. Indexing tab
[0098] The indexing tab 323 allows the ultrasound generation unit 3 to be reversibly locked relative to the ring 1 in a treatment position.
[0099] More specifically, the indexing tab 323 allows the ultrasound generation unit 3 to be immobilized (in rotation) in the ring 1 once a treatment position is reached.
[0100] With reference to [Fig. 10], the indexing tab 323 comprises: • an elastic leg 3231 with a return to its original shape, formed in the cylindrical barrel 321, • a cylindrical longitudinal bead 3232 configured to cooperate with the longitudinal grooves 135 of the gripping ring 13.
[0101] 2.2.2.2.7. Elastic tab
[0102] The elastic tab 3231 allows: • to engage the bead 3232 in a groove 135 opposite in order to prevent the rotation of the ultrasound generation unit 3 relative to the ring 1 (when no tangential support force is applied to the collar 3212), • to free the bead 3232 from the groove 135 in which it is engaged in order to allow the rotation of the ultrasound generation unit 3 relative to the ring 1 (when a tangential support force is applied to the collar 3212).
[0103] The elastic leg 3231 has a generally rectangular shape. It extends outward from the periphery of the cylindrical shaft 321, in a direction opposite to the cradle 31.
[0104] The elastic leg 3231 is connected to the cylindrical shaft 321 at a pivot joint whose pivot axis is tangent to the cylindrical shaft 321.
[0105] Thus, the elastic leg 3231 can be moved between: • a resting position in which said elastic leg 3231 extends overall in line with the cylindrical shaft 321, and • a disengagement position in which said elastic leg 3231 is inclined towards the inside of the cylindrical barrel 321.
[0106] When the elastic tab 3231 is in the rest position (bump 3232 housed in a groove 135), applying a tangential support force to the collar 3212 allows the elastic tab 3231 to be moved from the rest position to the position disengagement. It is thus possible for the practitioner to rotate the ultrasound generation unit 3 (relative to ring 1) from a given treatment position to a subsequent treatment position.
[0107] 2.2.2.2.2.2. Bead
[0108] The ridge 3232 extends radially outwards on the outer face of the elastic leg 3231.
[0109] As previously stated, the bead 3232 is intended to cooperate with the grooves 135 formed on the inner face of the cylindrical side face 133 of the gripping ring 13. The grooves 135 define successive processing positions for the transducers T.
[0110] When the bead 3232 of the indexing tongue 323 is engaged in a groove 135, the transducers T are in the processing position defined by this groove 135.
[0111] More specifically, when the elastic tab 3231 is in the resting position, then the ridge 3234 is engaged in a groove 135. The application by the practitioner of a supporting force: • tangential to the collar 3212, • in a direction perpendicular to the axis A-A', and • greater than a threshold value induces the movement of the elastic leg 3231 from the rest position to the disengaged position. The movement of the elastic leg 3231 towards the disengaged position — in which the elastic leg 3231 is inclined towards the inside of the cylindrical barrel 321 — induces the release of the bead from the groove 135 in which it is housed.
[0112] When the elastic tab 3231 is in the disengaged position, the application of a torsional force (by the practitioner) on the collar 3212 induces rotation, along the axis A-A', of the ultrasound generation unit 3 relative to the ring 1, even if this torsional force is less than the threshold value. This allows the rim 3234 to be moved to a new incision 135 to position the transducers T in a new treatment position.
[0113] Conversely, when the elastic tab 3231 is in the resting position, the application (by the practitioner) of a torsional force below the threshold value on the collar 3212 has no effect: the rotation of the ultrasound generation unit 3 relative to the ring 1 is prevented by the cooperation of the rim 3232 and the groove 135 in which it is housed. This makes it possible to lock the ring 1 and the ultrasound generation unit 3 together during the simultaneous treatment of two sectors of the patient's eye.
[0114] 2.2.2.2.3. Additional optional features
[0115] Advantageously, the indexing module 32 may also include a one-way blocking mechanism: • allowing the rotation of the ultrasound generation unit 3 relative to the ring 1 in a first direction (for example, clockwise), and • preventing the rotation of the ultrasound generation unit 3 relative to the ring 1 in a second direction opposite to the first direction (for example, counterclockwise).
[0116] The locking mechanism may for example include first and second groups of teeth (intended to cooperate and) positioned respectively on the cylindrical shaft 321 and on the ring 1, the teeth of said first and second groups being asymmetrical so that their cooperation allows the rotation of the ultrasound generation unit 3 in a single direction.
[0117] The presence of a one-way locking mechanism ensures that the practitioner always rotates the ultrasound generation unit 3 in the same direction relative to the ring 1 to reach successive treatment positions. This ensures that the patient's eye is treated in all successive treatment positions.
[0118] The indexing module 32 may further include a stop mechanism to prevent rotation of the ultrasound generation unit 3 relative to the ring 1 when all successive treatment positions have been occupied by the transducers T. This limits the risk of the same area of the patient's eye being treated several times.
[0119] With reference to [Fig. 11], the stopping mechanism may for example include a lug 139 housed in the annular groove (defined between the second termination 122 of the annular skirt 12 and the notch of the cylindrical lateral face 133 of the gripping ring 13) provided in the inner face of the ring 1. When the guide lug 322a, 322b is against the lug 139, the rotation of the ultrasonic generation unit is blocked.
[0120] 3. Use of the treatment device
[0121] We will now describe an example of a procedure for using the device to treat an ocular pathology such as glaucoma.
[0122] In one step, the practitioner positions the ring 1 on the patient's eye by grasping the pins 134 of the gripping ring 13 between their thumb and forefinger (for example, of their right hand). The fact that the walls of the components 11 and 12 ([Fig. 3]) constituting the ring are transparent makes it easier to center the ring 1 on the patient's eye.
[0123] The ultrasound generation unit 3 is then assembled onto the ring 1. For this purpose, the practitioner inserts the guide lug(s) 322a, 322b into the longitudinal groove(s) 138a, 138b. Each lug 322a, 322b slides inside its longitudinal groove 138a, 138b associated up to the annular groove, so that the transducers are totally immersed in the coupling fluid.
[0124] When the ultrasound generation unit 3 and the ring 1 are correctly assembled, the assembly is filled with coupling fluid. If the volume of coupling fluid introduced into the ring 1 is too great, the excess coupling fluid is drained through the through openings 134a provided under each pin 134 of the gripping ring 13. During the filling phase, the practitioner holds the ring 1 in position by holding it with the pins 134.
[0125] Once the lug(s) 322a, 322b are positioned in the annular groove, the practitioner applies a torsional force to the ultrasound generation unit 3 to rotate it relative to the ring 1 and reach the first treatment position. For this purpose, the practitioner grasps the collar 3212 of the ultrasound generation unit 3 between their thumb and forefinger (for example, of their left hand, while the thumb and forefinger of their right hand support the ring 1 by means of the pins 134 of the gripping ring 13).
[0126] When the ultrasonic generation unit 3 is in the first treatment position, the longitudinal bead 3232 is clipped into the longitudinal groove 135 defining the first position. With the bead 3232 housed in the groove 135, the ultrasonic generation unit 3 is prevented from rotating relative to the ring 1.
[0127] The practitioner then initiates the patient's treatment.
[0128] In particular, the practitioner activates the ultrasound generation unit 3. The T transducers generate high-intensity focused ultrasound. This ultrasound focuses at the ciliary body and induces the production of a first set of lesions in the ciliary body.
[0129] Once the first set of lesions has been produced, the ultrasound generation unit 3 is deactivated, and the ultrasound generation unit 3 is moved into a second treatment position.
[0130] To do this, the practitioner applies a tangential support force to the collar 3212. When this tangential support force exceeds the threshold value, the elastic tab 3231 moves from the rest position to the disengaged position. In particular, the elastic tab 3231 tilts inwards towards the cylindrical barrel 321. The bead 3234 is then freed from the groove 135.
[0131] The application of a torsional force (even of value less than the threshold value) by the practitioner induces the rotational displacement (along the axis A-A') of the ultrasound generation unit 3 relative to the ring 1. When the ultrasound generation unit 3 reaches the second treatment position, the ridge engages with the bleed 135 defining the second treatment position.
[0132] The practitioner can then activate the ultrasound generation unit 3 to produce a second set of lesions in the ciliary body.
[0133] The preceding steps are repeated for the different treatment positions. This makes it possible to treat different areas around the entire circumference of the patient's eye without moving ring 1.
[0134] By allowing the rotation of the ultrasound generation unit 3 relative to the ring 1, the treatment device according to the invention makes it possible to generate a number of lesions in the ciliary body greater than the number of transducers contained in the ultrasound generation unit 3, and guarantees the practitioner good treatment efficacy.
[0135] Moreover, the device described above makes it possible — at a lower manufacturing cost than the device described in WO 2021 / 122765 — to treat several areas distributed over the entire circumference of an eye without requiring the practitioner to carry out a repositioning operation of the ring 1 between each ultrasound emission.
[0136] The reader will have understood that many modifications can be made to the invention described above without materially departing from the new teachings and advantages described here.
Claims
Demands
1. A device for treating an ocular pathology, the device extending along a longitudinal axis (A-A') and comprising: • a ring (1) configured to be positioned on an eye to be treated, the ring (1) comprising: • a truncated cone (11) intended to come into contact with the eye to be treated, • a gripping ring (13) including a cylindrical lateral face (133) and extending over the truncated cone (11), • an ultrasound generation unit (3) configured to be mounted on the ring (1), the ultrasound generation unit (3) being adapted to move in rotation about the longitudinal axis (A-A') relative to the ring (1) in a plurality of successive treatment positions, characterized in that the ultrasound generation unit (3) comprises: • a cradle (31), including at least two transducers, and two hollowed-out zones (ZE1, ZE2) • an indexing module (32) defining the successive processing positions, the indexing module (32) being made of a transparent material and including a cylindrical shaft (321) whose external face is intended to face the internal face of the cylindrical side face (133).
2. Device according to claim 1, wherein: • the inner face of the cylindrical side face (133) has longitudinal grooves (135) extending parallel to the longitudinal axis (A-A'), • The indexing module (32) comprises an indexing tab (323) housed in a notch in the cylindrical shaft (321), said indexing tab (323) including an elastic leg (3231), and a longitudinal bead (3232) configured to cooperate with the longitudinal grooves (135), the longitudinal bead (3232) projecting outwards on the outer face of the leg elastic (3231), parallel to the longitudinal axis (A-A'), the indexing tab (323) being pivotally mounted about a pivot axis perpendicular to the longitudinal axis (A-A'), said indexing tab (323) being movable between: • a rest position in which the indexing tab (323) extends in line with the cylindrical barrel (321), the longitudinal bead (3232) being housed in a longitudinal groove (135) in the rest position so that the rotation of the ultrasonic generation unit (3) relative to the ring (1) is prevented, and • a disengagement position in which the indexing tab (323) is inclined towards the inside of the cylindrical barrel (321), the longitudinal bead (3232) being clear of the longitudinal groove (135) in the disengagement position so that the rotation of the ultrasound generation unit (3) relative to the ring (1) is permitted.
3. Device according to any one of claims 1 or 2, wherein the plurality of successive processing positions comprises an initial processing position, a final processing position, and at least one intermediate processing position between the initial and final processing positions, the device comprising a stop mechanism to prevent rotation of the ultrasound generating unit (3) relative to the ring (1) when the ultrasound generating unit is in the final position.
4. Device according to claim 3, wherein the stopping mechanism comprises: • at least one guide lug (322a, 322b) extending on the outer face of the cylindrical barrel (321) and configured to cooperate with an annular groove formed in the inner face of the ring (1), said and at least one guide lug (322a, 322b) moving inside the annular groove during rotation of the ultrasonic generation unit (3) relative to the ring (1), and • at least one nipple (139) housed in the annular throat, said and at least one nipple being in contact with said and at least one lug when the ultrasound generating unit is in the final position.
5. Processing device according to any one of claims 1 to 4, wherein: • the cylindrical side face (133) of the gripping ring (13) has a rim (132) opposite the truncated cone (11), said rim including positioning marks, each mark being associated with a longitudinal groove (135) to identify one processing position of the plurality of processing positions, and • the cylindrical barrel (321) has a collar (3212) intended to face the rim (132), said collar (3212) including a hole, the hole extending over a positioning mark when the longitudinal bead (3232) is housed in the longitudinal groove (135) associated with said positioning mark.
6. Treatment device according to any one of claims 1 to 5, wherein the cylindrical shaft (321) of the indexing module (32) has a crenellated collar (3212) intended to come into contact with an edge (132) of the gripping ring (13), said collar (3212) forming a gripping means enabling the practitioner to rotate the ultrasound generation unit (3) relative to the ring (1).
7. Processing device according to any one of claims 1 to 6, wherein the gripping ring (13) comprises a pair of pins (134) extending radially outwards from the cylindrical side face (133), and a pair of through openings (134a) allowing the flow of any excess coupling fluid contained in the ring, each through opening (134a) being positioned under a respective pin of the pair of pins (134).
8. Processing device according to any one of claims 1 to 7, wherein the ring is made of a transparent material.
9. A processing device according to any one of claims 2 to 8, wherein the elastic tab (3231), the longitudinal bead (3232) and the longitudinal grooves (135) are configured so that the application, by the practitioner, of a force tangential to the ring (1) and perpendicular to the axis (A-A') induces the displacement of the tongue (321) from the rest position to the disengagement position if said force is greater than a threshold value.